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Biotech / Medical : EntreMed (ENMD) -- Ignore unavailable to you. Want to Upgrade?

To: EPro who wrote (1964)	7/27/1999 10:12:00 AM
From: Don Dorsey	Read Replies (1) \| Respond to of 2135

EntreMed, Inc. Announces FDA Has Granted Permission For Endostatin Protein Clinical Trials to Begin Health & Medical Writers ROCKVILLE, Md--(BW HealthWire)--July 27, 1999--EntreMed, Inc. (NASDAQ:ENMD) announced today that it has been notified by the US Food and Drug Administration that "permission has been granted for the Endostatin(tm) protein clinical trials to begin." EntreMed's Investigational New Drug (IND) application for Endostatin(tm) protein was submitted to the FDA on June 24th, 1999. Permission to proceed with human clinical trials was received after FDA officials reviewed EntreMed's IND application for 30 days. With FDA permission to proceed now granted, and sufficient Endostatin(tm) protein already manufactured to GMP standards and vialed for human testing, EntreMed is now completing the final requirements which include receipt of protocol approvals from the Institutional Review Boards (IRBs) at each of the clinical trial sites, and quality assurance of the vialed GMP material. As previously announced, the first Phase I clinical trial to begin human safety testing and evaluation of Endostatin(tm) protein will be through Dana-Farber/Partners CancerCare, the joint-venture between Dana-Farber Cancer Institute, Brigham and Women's, and Massachusetts General Hospitals in Boston. Two additional Phase I clinical trial sites, sponsored by the National Cancer Institute (NCI), are the University of Texas M.D. Anderson Medical Center in Houston, and the University of Wisconsin Comprehensive Cancer Center in Madison. Dr. John W. Holaday, EntreMed Chairman, President and Chief Executive Officer commented: "In public statements over the past 12 months, we have indicated that the IND for Endostatin(tm) protein would be filed in the third quarter of 1999. As a result of our aggressive development schedule and the early completion of preclinical testing, I am pleased to report that the Company was able to file the IND in the second quarter, three months ahead of schedule. We continue to advance our product candidates to the clinic with expediency and efficiency, motivated by the belief that these naturally-occuring inhibitors of angiogenesis may provide a new, less toxic, resistance-free therapeutic option for cancer patients." Rockville, Md.-based EntreMed, Inc., The Angiogenesis Company(TM), is a leader in the field of antiangiogenesis research, which involves the inhibition of abnormal blood vessel growth recently associated with a broad range of diseases such as cancer and atherosclerosis. The Company's strategy is to accelerate development of its core technologies through collaborations and sponsored research programs with university medical departments, research companies and government laboratories. For further information, please visit the EntreMed web site at www.entremed.com. Statements herein that are not descriptions of historical facts are forward-looking and subject to risk and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in the Company's Securities and Exchange Commission filings under "Risk Factors," including risks relating to the early stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). --30--CF/ph* CONTACT: EntreMed, Inc. Mary P. Sundeen, Sr. Director, Corp. Communications, 301/738-2490